- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03622606
Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes (R-LAST)
This is a bi-centric study whose main objective is the validation of a rapid screening test for language disorders in the acute phase of right hemisphere stroke.
Primary objective
The main objective is the validation of a rapid language disorder screening tool that will be used in the acute phase of right hemispheric stroke.
Secondary objectives
Secondary objectives are:
- Characterize the "atypical crossed aphasia" since the acute phase of stroke with a large cohort of patients , which, to our knowledge, has never been done.
- Re-evaluate the number of patients with acute language disorder in right hemisphere stroke.
- Validate the use of R-LAST by different categories of carers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The R-LAST (Right Language screening test) comprises 8 subtests and a total of 15 items.
Validation will focus on the internal validity (no ceiling or floor effect, no redundancy, internal consistency), the external validity (against a "gold standard" in order to evaluate its specificity and its sensitivity) and the interclass agreement of R-LAST. The median time to administrate de scale will be calculated.
The investigators will validate the scale by administering it to 300 consecutive patients within 24 hours after admission to our 2 stroke units (Centre Hospitalier de Versailles and Centre hospitalier du sud francilien) and to 100 stabilized patients with and without atypical crossed aphasia using the MEC-P evaluation as a reference.
Patients must be 100% right-handed (Edinburgh test), be of French mother tongue, have no history of neurological disease, have no sensory disturbances (blindness, deafness) and no mirror crossed aphasia detected by the LAST (minimum score of 14/15 with a loss point granted for the "automatic speech" subtest, potentially stranded in right strokes)
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Corbeil-Essonnes, France, 91106
- CH SUd Francilien
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Le Chesnay, France, 78150
- CH de Versailles
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patients must be the age of majority
- Patients with right hemispheric stroke in the acute phase (internal validation + inter-examiner validation) or stabilization phase (external validation) confirmed by MRI or CT when MRI contraindicated
- Patient with no "mirror" crossed aphasia detected by the LAST procedure (A or B): LAST> 14
- Patients who read the newsletter
- Affiliation to a social security scheme
Criteria Exclusion:
- Minor patients
- No French speakers
- Patients with a history of stroke
- Patients with dementia
- Patients with sensory impairment: deafness, blindness
- Patient not 100% right handed in the Edinburgh questionnaire
- Inability to answer the Edinburgh Laterality Questionnaire and absence of any person to fill in the questionnaire.
- Patient with a left-handed person in its family
- Illiterate patients
- Patient presenting a "mirror" crossed aphasia detected by LAST A or B (score tolerated: 14/15 with error accepted to the automatic speech)
- Inability to receive the information letter about the protocol and to read the newsletter
- Refusal of the patient
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acute and subacute phase of right stroke
The intervention will be the passation of Right Language Screening Test (R-LAST). Patients in acute phase of right hemispheric stroke will be used for the internal validation and the integrated reliability of the Right Language screening test. Patients in subacute phase of right hemispheric stroke will be used for the external validation of the Right Language screening test. |
Validation of the Right Language screening test in acute and subacute phase of right stroke
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score at R-LAST
Time Frame: Day 1
|
Internal validation: no item will present effect floor, ceiling or of redundancy. Validation inter examiner: the score obtained to R-LAST is independent from the examiner. External validation: the patients detected by gold standard as presenting a speech difficulty bound to a right hemispherical lesion will also be him by R-LAST (no forgery negatives), and that the patients not presenting speech difficulty during the signing of these standard gold will obtain the maximum score to R-LAST (no forgery positive). |
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score at LAST A and B
Time Frame: Day 1
|
Detect the patients presenting a right hemispherical AVC with crossed aphasia "mirror"
|
Day 1
|
Time of signing R-LAST
Time Frame: Day 1
|
To obtain an average time of signing which will have to be shorter than that of the standard gold used during the external validation.
|
Day 1
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Simplicity and convenience of R-LAST
Time Frame: Day 1
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Contains only a sheet printed in black and white and both sides (to avoid the semantic indications bound to the color of an item, and to simplify the reproduction).
|
Day 1
|
Visual aspect of R-LAST
Time Frame: Day 1
|
Presentation in "portrait" mode, so that patients presenting a neurovisual disorder of type héminégligence or héminanopsie controlatérale are not penalized
|
Day 1
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Didier SMADJA, Neurologist, Sud Francilien Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P17/07_R-LAST
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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